Responsible Person and GDP Cogent Approved
The Responsible Person (RP) plays a critical role in ensuring that medicinal products are transported, stored and delivered in compliance with Good Distribution Practice (GDP). Given the complexities of this role, our training program equips delegates with essential knowledge and skills to navigate the complexities of this multifaceted role.
With over 25 years' experience in delivering highly impactful GDP training, our three-day RP course is led by industry leaders including ex MHRA inspector Tony Orme and practicing RPs. It incorporates the latest regulatory updates and best practices and is proudly Cogent Gold Standard approved, assuring you that it meets the rigorous standards set out by the MHRA.
Interested in RP training for your team? Contact us today.
This course is designed for people who are seeking to be named as a Responsible Person on a WDA and is relevant for professionals involved in the procurement and sale of medicinal products, including WDA holders. It will also benefit supplier auditors, existing RPs looking to enhance their CPD and trainee/QPs looking to gain a deeper understanding of GDP and the RP responsibilities.
Organisations applying for or holding a Wholesale Dealers Authorisation (WDA) must have a RP named on the license. The RP is responsible for ensuring compliance with GMP and understanding the legal responsibilities of holding a WDA license. This includes ensuring that all medicinal products in the legal supply chain are handled, transported, stored and distributed correctly.
Another core requirement of Good Distribution Practice is the need to have a well-designed Quality Management System (QMS) focused on compliance and continual improvement. The RP is legally required to ensure the QMS is implemented by maintaining oversite of its routine operation. This area will be covered in detail as it has been highlighted by the MHRA as the top area deficiencies are found during inspections.
The course includes the following topics:
Expectations to become a RP
Role of the RP and key regulatory requirements e.g. MHRA
What GDP covers and the license types
The WDA(H) and how to apply
License checks - Eudra GMDP & MHRA GMDP
Key personnel in the supply chain and GDP
Brexit
Quality management and its tools
Premises and equipment
Documentation and Operations
Complaints, returns, suspected falsified medicines and recalls
Outsourced activities
Self-inspection and regulatory inspections
Transportation, containers, packing and labelling, products requiring special conditions
Import and export
Specific provisions for brokers
Controlled drugs
Specific provisions for the RP
Responsibilities for the WDA holder
Parallel distribution
Attending this course will ensure that you:
Understand the role of the RP in personal responsibilities and patient/product user safety
Understand the legislation and licensing requirements for wholesale distribution of medicinal products
Have a clear understanding of the competent authority’s role in licensing of wholesale dealing of medicines and enforcing GDP guidelines
Understand the relevant role of national organisations that also regulate the supply chain of medicinal products
Understand all aspects of the European Pharmaceutical directives and guidelines related to GDP and be aware of GMP
Understand and recognise best practice in GDP and why it is essential in maintaining the quality and integrity of medicinal products
Appreciate how to implement an effective quality compliance system that can be maintained and improved
Are able to identify a medicinal product, the different legal categories, storage conditions and Marketing Authorisation (MA) types
Understand the importance of applying due diligence and when to report any suspicious events to senior management, the competent authority and the MA holder
Understand how to review the effectiveness of an organisation’s QMS and implement effective CAPAs
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
| Yes, the RP and GDP course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen RP and GDP course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the RP and GDP course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the RP and GDP course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
|
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
|
| Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees. All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK. |
| Our classroom courses are fully catered, and we provide all refreshments. If you have any special dietary requirements, please enter these into the ‘dietary requirements’ field when creating your account. Our virtual tutor-led courses will include a 45-minute lunch break. |
| It is very helpful to have some background knowledge of good distribution practice (GDP) before attending our Responsible Person and GDP Cogent approved course, as there is a knowledge test at the end of the course. So whilst the GDP course is not a prerequisite to being able to attend the RP course, it is certainlu recommended, depending on the level of knowledge you currently have. There are two GDP course options, our 1 Day Virtual tutor-led GDP course or our eLearning GDP course. Either option will provide a good level of understanding of GDP. |
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
